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ISO 11138-2 PDF

ISO Sterilization of health care products—Biological indicators— Part 2: Biological indicators for ethylene oxide sterilization processes. American. Summary: Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use. ISO Sterilization of health care products —. Biological indicators —. Part 2: Third edition. Reference number. ISO (E).

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Biological indicators for low-temperature steam and formaldehyde sterilization processes Who is this standard for?

We use cookies to make our website easier to use and to better understand your needs. The faster, easier way to work with standards. 111382 website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Requirements of population and resistance clause 9 revised, e.

Learn more about the cookies we use and how to change your settings. Standards exist providing requirements for the validation and control of ethylene oxide sterilization 11138- ISO and ISO This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.

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ANSI/AAMI/ISO (PDF)

General requirements Part 3: The following amendments have been made:. You may experience issues viewing this site in Internet Explorer 9, 10 or Biological indicators for ethylene oxide sterilization processes. Biological indicators for ethylene oxide sterilization processes Status: The following amendments have been made: The other parts of the standard are: Accept and continue Learn more about the cookies we use and how to change your settings. Biological indicators for moist heat sterilization processes Part 4: Click to learn more.

Biological indicators for dry heat sterilization processes Part 5: This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

This standard is a full technical revision of the version. Take the smart route to manage medical device compliance.

The intent is not to promote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today. Please download Chrome or Firefox or view our browser tips.

Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Find Similar Items This product falls into the following categories. Overview Product Details What is this standard about? Sterilization of health care products. Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard?

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Search all products by. Biological indicators Biological indicators for moist heat sterilization processes.

BS EN ISO 11138-2:2017

Your basket is empty. Organism-activity determination, Ethylene oxide, Microorganisms, Sterilization hygienePerformance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers.

You may find similar items within these categories by selecting from the choices below:. Part 1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including inoculated 11138–2 and suspensions intended for use in validation and monitoring of sterilization processes.

This is the second part of a five part standard the ISO series on the sterilization of health care products and biological indicators.